Job Description:
Position Summary
Scientific function responsible to support a global pharmacovigilance system (both development and post marketing). Scientific functions include but not limited to signal detection, risk assessment and management, Risk Management Plan (RMP) development, aggregate safety reporting, and clinical safety surveillance.
Key Job Responsibilities-
- Ensure that the benefit-risk assessment is current and that any changes are as per governance principles.
- Ensure patient safety for company’s products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe
- Timely completion of PV Assessment activities through product development, product maintenance and lifecycle management.
- Serve as a safety scientist on the medical safety team and participate in signal detection, risk management, mitigation plans, and safety analyses for aggregate reports and Health Authority responses.
- Participate in non-ICSR literature surveillance
- Ensure timely review, approval and communication of findings via SMT and governance forums.
Qualifications
Required:
Excellent communication and interpersonal skills and experience in mentoring others- Demonstrated qualities of competency, accountability, initiative, and leadership
- Experience in process improvement initiatives
- Extensive knowledge of US, ICH and EU PV and GCP regulations
- Experience with Risk Management and Signal Detection preferred
- Excellent strategic decision-making and analytical skills
- Strong leadership skills with excellent track record
- Computer skills including proficiency in use of Microsoft Word, Excel & PowerPoint
- Strong verbal, writing and organizational skills, including a good command of English
- Experience with Regulatory Authority Inspections (PV and GCP); experience managing vendors
- Medical writing experience
Education and Related Experience
- Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy or nursing degree) with at least 4 years of experience in clinical, pharmacological, or related fields of expertise
OR
- Bachelor’s degree in health sciences, nursing, pharmacy, public health, epidemiology or other relevant health-related field plus 10+ years of relevant experience in drug safety/pharmacovigilance, or related fields in the pharmaceutical industry.
